Medical device recalls Moderate risk

Philips Network Firewall recalled over fire hazard

Recall date
October 5, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Philips Electronics North America Corporation recalls Philips Network Firewall (Cisco ASA 5506), Model # 867098
Recall number
Z-0850-2018
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
US Nationwide

Why it was recalled

Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. This failure will result in loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Network Firewall (Cisco ASA 5506), Model # 867098

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